Background: Secukinumab, a fully human antiinterleukin 17A monoclonal antibody, was evaluated in ERASURE and FIXTURE, two phase 3 multicenter double blind vs placebo clinical studies for efficacy and safety in subjects with moderate to severe plaque psoriasis. Treatment effect was assessed using clinical measures such as the Psoriasis Area and Severity Index (PASI) and the ‘new’ psoriasis symptom diary (PSD), which measures both the severity and bothersomeness of psoriasis-related symptoms.
Methods: Patients aged ¼ 18 years were randomized 1:1:1 in ERASURE to receive subcutaneous treatment with secukinumab 300 mg, secukinumab 150 mg, or placebo; and 1:1:1:1 in FIXTURE which included etanercept 50 mg twice-weekly. Patients were asked to evaluate their psoriasis symptoms and experiences over the previous 24 hours. Weekly scores were derived as averages of daily 0-to-10 numerical ratings (higher scores indicative of greater severity/bothersomeness). Analyses focused on itching, pain and scaling. Absolute change from baseline to week 12 for the weekly average was analyzed using ANCOVA with covariates: geographical region, body weight stratum, and baseline value. Differences between treatment groups were determined using LS means and 95% CI. Among patients on secukinumab, differences in the bothersomeness of psoriasis-related symptoms between patients achieving clinical response (ie, PASI 90 or PASI 75) and those not achieving clinical response (not reaching PASI 75) at week 12 were also examined.
Results: Approximately 40% of patients completed the voluntary PSD. For the pooled analysis, subjects treated with secukinumab had significantly greater reductions in the bothersomeness of psoriasis-related itching, pain, and scaling than those treated with placebo or etanercept (all P \.01). Patients treated with secukinumab (ERASURE n ¼ 187, FIXTURE n ¼ 266) who achieved PASI 90 clinical response had greater reductions in PSD itching and scaling bothersomeness than those who achieved PASI 75, and both achieved greater relief than patients who did not achieve clinical response (all P \.05).
Conclusion: Secukinumab offered significantly greater relief of the bothersomeness of psoriasis-related itching, pain, and scaling compared to placebo or etanercept. Greater skin clearance as assessed by PASI (PASI 90 vs. PASI 75) was related to greater relief in the bothersomeness of patient-reported, psoriasis-related symptoms.
